EMA — authorised 23 June 1997
- Status: approved
🇪🇺 Cystagon in European Union
EMA authorised Cystagon on 23 June 1997
Marketing authorisations
EMA — authorised 24 June 2016
- Application: EMEA/H/C/004038
- Marketing authorisation holder: Lucane Pharma
- Local brand name: Dropcys
- Indication: Treatment of corneal cystine deposits
- Pathway: orphan
- Status: rejected
EMA — authorised 18 January 2017
- Application: EMEA/H/C/003769
- Marketing authorisation holder: Recordati Rare Diseases
- Local brand name: Cystadrops
- Indication: Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.
- Pathway: orphan
- Status: approved
Cystagon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Cystagon approved in European Union?
Yes. EMA authorised it on 23 June 1997; EMA authorised it on 24 June 2016; EMA authorised it on 18 January 2017.
Who is the marketing authorisation holder for Cystagon in European Union?
Mylan is the originator. The local marketing authorisation holder may differ — check the official source linked above.